WASHINGTON - There's a simple way of measuring whether an idea has caught on in Washington, Alan Bennett, an attorney who deals with FDA cases, told a small group gathered at one of BIO 2003's final sessions Wednesday.
"You can measure it by the number of meetings on the subject," Bennett said. "Last year at BIO there weren't any meetings on follow-on biologics [generic biologics]; this year there are three, not counting other meetings around town."
Bennett, a partner at the law firm Ropes & Gray, chaired a four-man panel of experts charged with hashing out regulatory policies, clinical trial standards and manufacturing processes that may be involved in developing generic biologics.
Everyone seemed to agree that the prospect of generic biologics is not some dream out of left field. On the contrary, Bennett said as recently as last Monday Sen. Orrin Hatch (R-Utah) confirmed that generic makers likely will get a chance to delve into biologics at some point. Hatch is one of the authors of the Hatch-Waxman Act of 1984, the legislation credited with creating the generic drug industry. (Sen. Henry Waxman, a California Democrat, was the co-author.)
And there's other proof, too, Bennett said. Take for example consolidation of certain responsibilities at the drug and biologics divisions of the FDA. While that move was billed last summer as a necessary step toward speeding review times of biologics, many industry watchers interpreted it to mean something else. Whatever the case, the consolidation will be effective June 30. (See BioWorld Today, Sept. 9, 2002).
Most biologics are approved under the Public Health Service Act, and according to Richard Kingham, a panel member and partner with Covington & Burling, FDA officials have made statements over the years that they don't have authority under this law to approve generics.
But the Federal Food, Drug and Cosmetic Act (FDCA), the law under which most pharmaceuticals are approved, does give the FDA power to clear abbreviated approvals for generics. Certain biotech products, like insulin and human growth hormone, were approved under FDCA, a point that has stirred a little concern.
In the last couple of months the Biotechnology Industry Organization sent a 70-page petition to the FDA asking the agency to solicit public participation on scientific, legal and policy issues before adopting any new pathways, regardless of how small or insignificant they may seem. (See BioWorld Today, April 28, 2003.)
BIO worries that the agency will allow follow-on approvals of certain therapeutic protein products regulated as new drugs under FDCA, including recombinant products.
Indeed, Kingham sees it the same way. "There are a number of biologics that have been approved [under the law for] ordinary drugs. Theoretically they are subject to [being developed] as generics," he said.
Many industry watchers fear the FDA, driven by political pressure to help reduce the costs of prescription drugs, will slowly begin approving generic biologics under that act.
BIO said it was prompted to draw up the petition following public comments made by FDA officials as to the future of generic biologics.
Specifically, BIO was speaking of a Food and Drug Law Institute meeting here in early April when FDA Commissioner Mark McClellan said the agency's long-term goal is to create a regulatory and scientific pathway for generic biologics. (See BioWorld Today, April 2, 2003.)
However, Lester Crawford, deputy FDA commissioner, said at the Wall Street Transcript conference in New York in March that there are difficulties associated with the idea of generic biologics. "It's not moving very fast," he said of generic biologics, "and nothing will happen with that in this administration."
As part of his presentation Wednesday, Steve Bende, a panel member and vice president, scientific affairs, at the Washington-based Generic Pharmaceutical Association, flashed a McClellan quote from last fall on the screen that said: "The feasibility of interchangeable or generic biologics should be assessed further and should rely on scientific knowledge and experience as key factors."
So, McClellan wasn't very clear on what is going to happen and when.
Some biotech officials, such as Fred Bader, a panel member and vice president of process sciences at Centocor Inc., of Malvern, Pa., said follow-on biologics should and will happen. "The question is whether they will have different standards. Will they fall under the same rules as innovator products or will standards be lowered? It will be surprising if follow-on biopharmaceutical products aren't held to the same standards as innovator drugs."
Key comparability issues for follow-on biologics likely would be general safety, potency, host cell contaminants (DNA, host cell proteins), immunogenicity, pharmacokinetics and pharmacodynamics.
When asked by an audience member whether it would be extremely difficult for generic companies to develop copy products without going to the innovator and asking for assays, Bader said generic companies should probably expect to find themselves in front of the FDA.
"Generally, you can't get that type of information, so you have to speculate," Bader said. "But the FDA has sharp people who know the products. They can't tell you certain tests another company ran, but they can make suggestions."